Parents have been “falsely reassured” by commercially available home fetal heart monitors, the regulator says.
The TGA has launched an investigation into home-use fetal heart monitors, urging clinicians to caution parents against them. While used regularly in healthcare settings, handheld fetal doppler devices have become available to untrained consumers over the last few years.
Now, the TGA says it has become aware of cases in which parents concerned about the health of their unborn child used a fetal doppler incorrectly and delayed seeking medical attention as a result.
“Without training, the sounds detected from the mother or placenta could easily be misinterpreted as the fetal heartbeat, providing potentially inaccurate reassurance,” the regulatory agency said.
Both RANZCOG and the US Food and Drug Administration already recommend against using the devices to detect fetal heartbeat in a home setting.
In a 2009 position statement, the Australian and New Zealand Stillbirth Alliance said there was no evidence to indicate that home fetal heart monitoring devices have a role as a surveillance tool to improve pregnancy outcomes.
“Pregnant women who are concerned about their baby’s health, such as a decrease in movements, should seek advice from their health care provider and not rely on the use of fetal heart monitors used at home,” said the alliance.
The TGA’s new investigation will help determine whether the risk of false reassurance outweighs the potential benefit of the home-use devices.
In the meantime, healthcare staff are advised to caution expectant parents about the potential risks involved in relying on the device to make a judgement.
The TGA urged clinicians and consumers to report any suspected adverse events where a home fetal doppler was implicated.
